Transvaginal mesh not superior to native tissue repair for treating pelvic organ prolapse: Study
USA: At 36 months, transvaginal mesh repair was not found to be superior to native tissue repair for the treatment of anterior and/or apical vaginal prolapse, according to a recent study in Obstetrics & Gynecology.
Also, an important consideration from the patient-experience perspective, subjective success was high and not statistically different between groups. Transvaginal mesh repair was equally safe as native tissue repair with regard to serious device-related and/or serious procedure-related adverse events.
The study was conducted by Bruce Kahn, FACOG, an OB/GYN at Scripps Clinic in San Diego, and colleagues with the aim to compare the safety and effectiveness of transvaginal mesh repair and native tissue repair, in response to a U.S. Food and Drug Administration (FDA) 522 study order to assess co-primary endpoints of superiority and noninferiority in a prospective, nonrandomized, parallel cohort, multi-center trial.
The trial compared transvaginal mesh with native tissue repair for the treatment of pelvic organ prolapse. The primary endpoints were composite treatment success at 36 months comprised of subjective success (vaginal bulging per the PFDI-20 [Pelvic Floor Distress Inventory]), anatomical success (defined as pelvic organ prolapse quantification [POP-Q] point Ba≤0 and/or C≤0), and retreatment measures, as well as rates of serious device-related or serious procedure-related adverse events.
Secondary endpoints included a composite outcome similar to the primary composite outcome but with anatomical success defined as POP-Q point Ba<0 and/or C<0, quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
Key findings of the study include:
- Primary endpoint composite success at 36 months was 89.3% (201/225) for transvaginal mesh and 80.2% (389/485) for native tissue repair, demonstrating noninferiority at the preset margin of 12% (propensity score-adjusted treatment difference 6.5%).
- Using the primary composite endpoint, transvaginal mesh was not superior to native tissue repair.
- Using the secondary composite endpoint, superiority of transvaginal mesh over native tissue repair was noted, with a propensity score-adjusted difference of 10.6% in favor of transvaginal mesh.
- Subjective success for both the primary and secondary endpoint was 92.4% for transvaginal mesh, 92.8% for native tissue repair, and a propensity score-adjusted difference of −4.3%.
- For the primary safety endpoint, 3.1% (7/225) of patients in the transvaginal mesh (TVM) group and 2.7% (13/485) of patients in the native tissue repair (NTR) group developed serious adverse events, demonstrating that transvaginal mesh was noninferior to native tissue repair (−0.4%).
- Overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) in the TVM group and 46.4% (225/485) in the NTR group (−15.7%).
"In a prospective cohort 36-month study, transvaginal mesh was not inferior to, and was as safe as native tissue repair, for treatment of pelvic organ prolapse," wrote the authors.
Reference:
Kahn, Bruce MD; Varner, R. Edward MS, MD; Murphy, Miles MD; Sand, Peter MD; Thomas, Sherry MD, MPH; Lipetskaia, Lioudmila MD, MS; Chung, Doreen E. MD, FRCSC; Mahdy, Ayman MD, PhD; Noblett, Karen MD, MBA Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse, Obstetrics & Gynecology: June 2022 - Volume 139 - Issue 6 - p 975-985 doi: 10.1097/AOG.0000000000004794
